MITRATHANE DRESSING— 510(k) K850535

Name: FDA 510(k) clearance K850535
Creator: U.S. Food and Drug Administration
Published: 1985-06-05

Substantially Equivalent for Some Indications

Mitral Medical , Ltd.

FDA 510(k) clearance K850535 for MITRATHANE DRESSING, Substantially Equivalent for Some Indications on 1985-06-05. Applicant: Mitral Medical , Ltd.. Device class: 1.

Clearance details

Applicant: Mitral Medical , Ltd.
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
Advisory panel: General, Plastic Surgery
Date received: 1985-02-11
Decision date: 1985-06-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.